Risk Behavior, HealthNCT05878743
A Qualitative Mixed Methods Realist Evaluation of Safety Planning
An observational study of Risk Behavior, Health, run by King's College London.
Trial summary
Safety Planning is a recovery-orientated approach to risk management within mental health context. This study wants to answer the question 'how, why, for whom and it what circumstances does safety planning work? It will do this by carrying out a realist evaluation to identify programme theories by conducting a three… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Risk Behavior, Health
- What is being tested?
- Safety Planning a recovery-orientated mental health risk management intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 16 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Mental health service users accessing a service from Norfolk \& Suffolk NHS Foundation Trust, Carers (family members, friends) of someone accessing a service from NSFT and Mental Health practitioners.
Who may be able to join
- Service user participants - must have direct lived experience of managing safety from risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered within Norfolk \& Suffolk NHS Foundation Trust (NSFT) / Be accessing a service from NSFT and have an identified care team, lead care professional and/or know how to access help and support.
- Carer participants - have cared for someone who lived with risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered by NSFT / know how to access emotional support should they require it during the study Mental health professionals - have either a) supported people in a professional capacity to manage risks associated with mental health difficulties, b) attended either the safety planning recovery college course (NSFT) OR a version of safety planning training delivered within NSFT c) have some responsibility for safety planning and risk management within the trust. MUST HAVE knowledge of how to access staff wellbeing and support systems for emotional support should they require it during the study.
Who cannot join
- People under 16 years of age / people who are unable to communicate in English / people with no access to computer, internet or basic IT skills /
About this study
Official title: A Survivor Researcher-led Qualitative Mixed Methods Realist Evaluation of Safety Planning: a Recovery-orientated Mental Health Risk Management Intervention.
Safety Planning is a recovery-orientated approach to risk management within mental health context. This study wants to answer the question 'how, why, for whom and it what circumstances does safety planning work? It will do this by carrying out a realist evaluation to identify programme theories by conducting a three phase study, reviewing materials of a Safety Planning training course, interviewing service users, carers and mental health professionals who have attended the training course, and/or use safety planning tools and techniques, adopting theory from existing literature and adding evaluator's insider knowledge. This data will be used to describe programme theory of safety planning that can be applied across diverse mental health settings, including NHS inpatient and community, and is designed to be adopted across different contexts. It will use a realist methodology to understand how safety planning works to develop the skills needed to manage risks associated with mental health difficulties in ways which increase an individual's quality of life.
- Conditions
- Risk Behavior, Health
- Being tested
- Safety Planning a recovery-orientated mental health risk management intervention
- Medical subject headings
- Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Planning a recovery-orientated mental health risk management interventionBehavioural
Developing the skills to manage risks associated with mental health difficulties in ways which increase personal recovery for individuals.
What is being measured
The primary outcome is the main question the study is designed to answer.
Formal theory described which explains how, why, for whom and in what circumstances safety planning works.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Apr 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion16 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Behavior, HealthStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878743
- Sponsor's protocol ID
- 293012
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survivor Researcher-led Qualitative Mixed Methods Realist Evaluation of Safety Planning: a Recovery-orientated Mental Health Risk Management Intervention.
- ClinicalTrials.gov ID
- NCT05878743
- Acronym / sponsor ID
- 293012
- Conditions
- Risk Behavior, Health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 16 May 2027 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety Planning is a recovery-orientated approach to risk management within mental health context. This study wants to answer the question 'how, why, for whom and it what circumstances does safety planning work? It will do this by carrying out a realist evaluation to identify programme theories by conducting a three phase study, reviewing materials of a Safety Planning training course, interviewing service users, carers and mental health professionals who have attended the training course, and/or use safety planning tools and techniques, adopting theory from existing literature and adding evaluator's insider knowledge. This data will be used to describe programme theory of safety planning that can be applied across diverse mental health settings, including NHS inpatient and community, and is designed to be adopted across different contexts. It will use a realist methodology to understand how safety planning works to develop the skills needed to manage risks associated with mental health difficulties in ways which increase an individual's quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Mental health service users accessing a service from Norfolk \& Suffolk NHS Foundation Trust, Carers (family members, friends) of someone accessing a service from NSFT and Mental Health practitioners.
Key inclusion criteria (2 listed)
- Service user participants - must have direct lived experience of managing safety from risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered within Norfolk \& Suffolk NHS Foundation Trust (NSFT) / Be accessing a service from NSFT and have an identified care team, lead care professional and/or know how to access help and support.
- Carer participants - have cared for someone who lived with risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered by NSFT / know how to access emotional support should they require it during the study Mental health professionals - have either a) supported people in a professional capacity to manage risks associated with mental health difficulties, b) attended either the safety planning recovery college course (NSFT) OR a version of safety planning training delivered within NSFT c) have some responsibility for safety planning and risk management within the trust. MUST HAVE knowledge of how to access staff wellbeing and support systems for emotional support should they require it during the study.
Key exclusion criteria (1 listed)
- People under 16 years of age / people who are unable to communicate in English / people with no access to computer, internet or basic IT skills /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Planning a recovery-orientated mental health risk management interventionDeveloping the skills to manage risks associated with mental health difficulties in ways which increase personal recovery for individuals. | Behavioural | – |
Primary outcome
Formal theory described which explains how, why, for whom and in what circumstances safety planning works.
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Behavior, Health, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formal theory described which explains how, why, for whom and in what circumstances safety planning works. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.